Patient Safety and Quality Improvement Act of 2004 - Amends the Public Health Service Act to designate patient safety data as privileged and not subject to: (1) a subpoena, discovery, disclosure, or admission as evidence in any Federal, State, or local civil, criminal, or administrative proceeding; (2) disclosure pursuant to a Freedom of Information Act request; or (3) use in a disciplinary proceeding against a provider. Defines "patient safety data" as any data, reports, records, memoranda, analyses, or statements that could result in improved patient safety, health care quality, or health care outcomes.
Designates patient safety data as confidential, but permits the disclosure of patient safety data by a provider or patient safety organization (PSO) if such disclosure is a voluntary disclosure of non-identifiable data or if such data: (1) contains evidence, to be used in a criminal proceeding, of a wanton and criminal act to directly harm the patient; (2) is disclosed to a provider or patient safety organization to carry out patient safety organization activities; (3) is disclosed to carry out authorized patient safety research; (4) is disclosed to an accrediting body of a provider; or (5) is voluntarily disclosed for public health surveillance with the consent of each provider who provided or who is identified in such data. Defines "patient safety organization" as an organization certified by the Secretary of Health and Human Services that conducts efforts to improve patient safety and the quality of health care delivery through the collection and analysis of patient safety data.
Declares that privilege and confidentiality of patient safety data continues for disclosures under this Act, except for data that is disclosed in open court or that is non-identifiable. Prohibits any action against a PSO to compel disclosure of information, unless such information is specifically identified, is not patient safety data, and cannot otherwise be obtained.
Prohibits an accrediting body from: (1) taking any accrediting action against a provider based on the provider's good faith participation in collecting, developing, reporting or maintaining patient safety data; or (2) requiring a provider to reveal its communications with any PSO. Prevents a provider from taking an adverse employment action against an individual based upon the good faith reporting of information. Allows the Secretary to impose and collect fines for the negligent or intentional disclosure of patient safety data in violation of the confidentiality provisions of this Act.
Allows civil actions for violations of this Act.
Provides that the privilege provided for under this Act does not apply to States or State entities, unless such State has consented to be subject to such civil actions.
Declares that this Act does not: (1) limit other privileges available that provide greater confidentiality protections under Federal, State, or local laws; (2) affect the requirements of Federal, State, or local law pertaining to patient-related data that is not privileged or confidential under this Act; (3) affect the implementation of the Health Insurance Portability and Accountability Act of 1996 or the Social Security Act; (4) limit the authority of providers or PSOs from contracting to require greater confidentiality or delegate the authority to make permitted disclosures; or (5) prohibit a provider from reporting crime to law enforcement authorities, so long as the provider does not disclose patient safety data in making such a report.
Requires the Secretary to maintain a patient safety network of databases that has the capacity to accept, aggregate, and analyze non-identifiable patient safety data voluntarily reported and that provides an interactive resource for providers and PSOs. Allows the Secretary to determine common formats for reporting to the databases. Provides that such formats shall be consistent with the administration simplification provisions of the Social Security Act.
Requires PSOs to submit an initial certification to the Secretary and to renew their certification every three years. Requires the Secretary to: (1) compile and maintain a current list of certified PSOs; and (2) remove from the list entities whose certification expires or is revoked. Makes provisions for the patient safety data if a PSO's certification is expired or revoked.
Allows the Secretary, acting through the Director of the Agency for Healthcare Research and Quality, to provide technical assistance to PSOs.
Directs the Secretary to: (1) develop or adopt voluntary national standards, within three years, to promote the electronic exchange of health care information; (2) provide for the ongoing review and periodic updating of these standards; and (3) disseminate these standards and updates.
Authorizes appropriations.
Directs the Secretary to contract with a research organization to study: (1) the extent to which labor and technological advances have contributed to increased national spending on health care; (2) the extent to which the early introduction and integration of innovative medical technologies and therapies may affect the overall productivity and quality of health care; and (3) the relationship of such technologies and therapies to patient safety, patient benefit, health care quality, and health care costs.
Sets forth reporting requirements.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 663 Introduced in House (IH)]
108th CONGRESS
1st Session
H. R. 663
To amend title IX of the Public Health Service Act to provide for the
improvement of patient safety and to reduce the incidence of events
that adversely affect patient safety, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 11, 2003
Mr. Bilirakis (for himself, Mr. Brown of Ohio, Mr. Tauzin, Mr. Dingell,
Mr. Barton of Texas, Mr. Waxman, Mr. Upton, Mr. Markey, Mr. Greenwood,
Mr. Towns, Mr. Burr, Mr. Pallone, Mr. Whitfield, Mr. Gordon, Mr.
Norwood, Mr. Deutsch, Mr. Terry, Mr. Rush, Mr. Rogers of Michigan, Mr.
Engel, Mr. Wynn, Ms. McCarthy of Missouri, Mr. Strickland, Mrs. Capps,
Mr. John, and Ms. Harman) introduced the following bill; which was
referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend title IX of the Public Health Service Act to provide for the
improvement of patient safety and to reduce the incidence of events
that adversely affect patient safety, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Patient Safety and Quality
Improvement Act''.
SEC. 2. FINDINGS AND PURPOSES.
(a) Findings.--The Congress finds as follows:
(1) In 1999, the Institute of Medicine released a report
entitled ``To Err Is Human'' that described medical errors as
the 8th leading cause of death in the United States, with as
many as 98,000 people dying as a result of medical errors each
year.
(2) To address these deaths and injuries due to medical
errors, the health care system must identify and learn from
such errors so that systems of care can be improved.
(3) Myriad public and private patient safety initiatives
have begun. The Quality Interagency Coordination Task Force has
recommended steps to improve patient safety that may be taken
by each Federal agency involved in health care and activities
relating to these steps are ongoing.
(4) The Department of Health and Human Services has
initiated several patient safety projects. The Joint Commission
on Accreditation of Healthcare Organizations issued a patient
safety standard that went into effect on July 1, 2001, and the
peer review organizations are conducting ongoing studies of
clinical performance measurement of care delivered to
beneficiaries under the medicare program under title XVIII of
the Social Security Act.
(5) Several steps can be taken now to improve patient
safety. For example, according to the Centers for Disease
Control and Prevention, hand washing is the single most
important means of preventing the spread of infection. Repeated
studies indicate that lack of or improper hand washing still
contributes significantly to disease transmission in health
care settings. Working with experts from the private sector,
the Centers for Disease Control and Prevention has drafted
``Guidelines for Hand Hygiene in Healthcare Settings'' setting
forth recommendations to promote improved hand hygiene
practices and reduce transmission of pathogenic microorganisms
to patients and personnel in health care settings.
(6) According to the Centers for Disease Control and
Prevention, nosocomial infections affect approximately 2
million patients annually in acute care facilities in the
United States at an estimated direct patient care cost of
approximately $3.5 billion each year.
(7) The Congress encourages the continuation and
acceleration of private sector efforts to take immediate steps
to improve patient safety and recognizes the need for action in
the public sector to complement these efforts.
(8) The research on patient safety unequivocally calls for
a learning environment, where providers will feel safe to
report health care errors, in order to improve patient safety.
(9) Voluntary data gathering systems are more supportive
than mandatory systems in creating the learning environment
referred to in paragraph (8) as stated in the Institute of
Medicine's report.
(10) Promising patient safety reporting systems have been
established throughout the United States, and the best ways to
structure and use these systems are currently being determined,
largely through projects funded by the Agency for Healthcare
Research and Quality.
(11) Many organizations currently collecting patient safety
information have expressed a need for protections that will
allow them to review protected information so that they may
collaborate in the development and implementation of patient
safety improvement strategies. Currently, the State peer review
protections provide inadequate conditions to allow the sharing
of information to promote patient safety.
(12) In 2001, the Institute of Medicine released a report
entitled ``Crossing the Quality Chasm'' that found that the
United States health care system does not consistently deliver
high-quality care to patients.
(b) Purposes.--The purposes of this Act are--
(1) to encourage a culture of safety and quality in the
United States health care system by providing for a health care
errors reporting system that both protects information and
improves patient safety and quality of health care; and
(2) to ensure accountability by raising standards and
expectations for continuous quality improvements in patient
safety through the actions of the Secretary of Health and Human
Services.
SEC. 3. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.
(a) In General.--Title IX of the Public Health Service Act (42
U.S.C. 299 et seq.) is amended--
(1) in section 912(c), by inserting ``, in accordance with
part C,'' after ``The Director shall'';
(2) by redesignating part C as part D;
(3) by redesignating sections 921 through 928, as sections
931 through 938, respectively;
(4) in section 938(1) (as so redesignated), by striking
``921'' and inserting ``931''; and
(5) by inserting after part B the following:
``PART C--PATIENT SAFETY IMPROVEMENT
``SEC. 921. DEFINITIONS.
``In this part:
``(1) Identifiable information.--The term `identifiable
information' means information that is presented in a form and
manner that allows the identification of any provider, patient,
or reporter of patient safety work product. With respect to
patients, such information includes any individually
identifiable health information as that term is defined in the
regulations promulgated pursuant to section 264(c) of the
Health Insurance Portability and Accountability Act of 1996
(Public Law 104-191; 110 Stat. 2033).
``(2) Nonidentifiable information.--The term
`nonidentifiable information' means information that is
presented in a form and manner that prevents the identification
of any provider, patient, or reporter of patient safety work
product. With respect to patients, such information must be de-
identified consistent with the regulations promulgated pursuant
to section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191; 110 Stat.
2033).
``(3) Patient safety evaluation system.--The term `patient
safety evaluation system' means a process that involves the
collection, management, or analysis of information for
submission to or by a patient safety organization.
``(4) Patient safety organization.--The term `patient
safety organization' means a private or public organization or
component thereof that is certified, through a process to be
determined by the Secretary under section 925, to perform each
of the following activities:
``(A) The conduct, as the organization or
component's primary activity, of efforts to improve
patient safety and the quality of health care delivery.
``(B) The collection and analysis of patient safety
work product that is submitted by providers.
``(C) The development and dissemination of
evidence-based information to providers with respect to
improving patient safety, such as recommendations,
protocols, or information regarding best practices.
``(D) The utilization of patient safety work
product to carry out activities limited to those
described under this paragraph and for the purposes of
encouraging a culture of safety and of providing direct
feedback and assistance to providers to effectively
minimize patient risk.
``(E) The maintenance of confidentiality with
respect to identifiable information.
``(F) The provision of appropriate security
measures with respect to patient safety work product.
``(G) The submission of nonidentifiable information
to the Agency consistent with standards established by
the Secretary under section 923(b) for any National
Patient Safety Database.
``(5) Patient safety work product.--
``(A) The term `patient safety work product' means
any document or communication (including any
information, report, record, memorandum, analysis,
deliberative work, statement, or root cause analysis)
that--
``(i) except as provided in subparagraph
(B), is developed by a provider for the purpose
of reporting to a patient safety organization,
and is reported to a patient safety
organization;
``(ii) is created by a patient safety
organization; or
``(iii) would reveal the deliberations or
analytic process of a patient safety evaluation
system (as defined in paragraph (3)).
``(B)(i) Patient safety work product described in
subparagraph (A)(i)--
``(I) does not include any separate
information described in clause (ii); and
``(II) shall not be construed to include
such separate information merely by reason of
inclusion of a copy of the document or
communication involved in a submission to, or
the fact of submission of such a copy to, a
patient safety organization.
``(ii) Separate information described in this
clause is a document or communication (including a
patient's medical record or any other patient or
hospital record) that is developed or maintained, or
exists, separately from any patient safety evaluation
system.
``(C) Information available from sources other than
a patient safety work product under this section may be
discovered or admitted in a civil or administrative
proceeding, if discoverable or admissible under
applicable law.
``(6) Provider.--The term `provider' means--
``(A) an individual or entity licensed or otherwise
authorized under State law to provide health care
services, including--
``(i) a hospital, nursing facility,
comprehensive outpatient rehabilitation
facility, home health agency, and hospice
program;
``(ii) a physician, physician assistant,
nurse practitioner, clinical nurse specialist,
certified nurse midwife, psychologist,
certified social worker, registered dietitian
or nutrition professional, physical or
occupational therapist, or other individual
health care practitioner;
``(iii) a pharmacist; and
``(iv) a renal dialysis facility,
ambulatory surgical center, pharmacy, physician
or health care practitioner's office, long-term
care facility, behavioral health residential
treatment facility, clinical laboratory, or
community health center; or
``(B) any other person or entity specified in
regulations by the Secretary after public notice and
comment.
``SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PRODUCT.
``(a) Privilege.--Notwithstanding any other provision of law and
subject to subsection (c), patient safety work product shall not be--
``(1) subject to a civil or administrative subpoena or
order;
``(2) subject to discovery in connection with a civil or
administrative proceeding;
``(3) subject to disclosure pursuant to section 552 of
title 5, United States Code (commonly known as the Freedom of
Information Act), or any other similar Federal or State law;
``(4) required to be admitted as evidence or otherwise
disclosed in any State or Federal civil or administrative
proceeding; or
``(5) if the patient safety work product is identifiable
information and is received by a national accreditation
organization in its capacity as a patient safety organization--
``(A) used by a national accreditation organization
in an accreditation action against the provider that
reported the information;
``(B) shared by such organization with its survey
team; or
``(C) required as a condition of accreditation by a
national accreditation association.
``(b) Reporter Protection.--
``(1) In general.--A provider may not use against an
individual in an adverse employment action described in
paragraph (2) the fact that the individual in good faith
reported information--
``(A) to the provider with the intention of having
the information reported to a patient safety
organization; or
``(B) directly to a patient safety organization.
``(2) Adverse employment action.--For purposes of this
subsection, an `adverse employment action' includes--
``(A) the failure to promote an individual or
provide any other employment-related benefit for which
the individual would otherwise be eligible;
``(B) an adverse evaluation or decision made in
relation to accreditation, certification,
credentialing, or licensing of the individual; and
``(C) a personnel action that is adverse to the
individual concerned.
``(3) Remedies.--Any provider that violates this subsection
shall be subject to a civil monetary penalty of not more than
$20,000 for each such violation involved. Such penalty shall be
imposed and collected in the same manner as civil money
penalties under subsection (a) of section 1128A of the Social
Security Act are imposed and collected.
``(c) Disclosures.--Nothing in this section prohibits any of the
following disclosures:
``(1) Voluntary disclosure of nonidentifiable information.
``(2) Voluntary disclosure of identifiable information by a
provider or patient safety organization, if such disclosure--
``(A) is authorized by the provider for the
purposes of improving quality and safety;
``(B) is to an entity or person subject to the
requirements of section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (Public Law
104-191; 110 Stat. 2033), or any regulation promulgated
under such section; and
``(C) is not in conflict with such section or any
regulation promulgated under such section.
``(3) Disclosure as required by law by a provider to the
Food and Drug Administration, or on a voluntary basis by a
provider to a federally established patient safety program,
with respect to an Administration-regulated product or activity
for which that entity has responsibility, for the purposes of
activities related to the quality, safety, or effectiveness of
such Administration-regulated product or activity.
``(4) Disclosures of patient safety work product in
accordance with this part by a provider to a patient safety
organization.
``(d) Effect of Transfer, Disclosure.--The following shall not be
treated as a waiver of any privilege or protection established under
this part:
``(1) The transfer of any patient safety work product
between a provider and a patient safety organization.
``(2) Disclosure of patient safety work product as
described in subsection (c).
``(3) The unauthorized disclosure of patient safety work
product.
``(e) Penalty.--
``(1) Prohibition.--Except as provided in this part, and
subject to paragraphs (2) and (4), it shall be unlawful for any
person to disclose patient safety work product in violation of
this section, if such disclosure constitutes a negligent or
knowing breach of confidentiality.
``(2) Relation to HIPAA.--The penalty under paragraph (3)
for a disclosure in violation of paragraph (1) does not apply
if the person would be subject to a penalty under section
264(c) of the Health Insurance Portability and Accountability
Act of 1996 (Public Law 104-191; 110 Stat. 2033), or any
regulation promulgated under such section, for the same
disclosure.
``(3) Amount.--Any person who violates paragraph (1) shall
be subject to a civil monetary penalty of not more than $10,000
for each such violation involved. Such penalty shall be imposed
and collected in the same manner as civil money penalties under
subsection (a) of section 1128A of the Social Security Act are
imposed and collected.
``(4) Subsequent disclosure.--Paragraph (1) applies only to
the first person that breaches confidentiality with respect to
particular patient safety work product.
``(f) Relation to HIPAA.--
``(1) In general.--For purposes of applying the regulations
promulgated pursuant to section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (Public Law 104-191; 110
Stat. 2033)--
``(A) patient safety organizations shall be treated
as business associates; and
``(B) activities of such organizations described in
section 921(4) in relation to a provider are deemed to
be health care operations (as defined in such
regulations) of the provider.
``(2) Rule of construction.--Nothing in this section shall
be construed to alter or affect the implementation of such
regulations or such section 264(c).
``(g) No Limitation of Other Privileges.--Nothing in this section
shall be construed to affect privileges, including peer review and
confidentiality protections, that are otherwise available under Federal
or State laws.
``(h) No Limitation on Contracts.--Nothing in this section shall be
construed to limit the power of a provider and a patient safety
organization, or a patient safety organization and the Agency or any
National Patient Safety Database, consistent with the provisions of
this Act and other applicable law, to enter into a contract requiring
greater confidentiality or delegating authority to make an authorized
disclosure.
``(i) Relation to State Reporting Requirements.--Nothing in this
part shall be construed as preempting or otherwise affecting any State
law requiring a provider to report information, including information
described in section 921(5)(B), that is not patient safety work
product.
``(j) Continuation of Privilege.--Patient safety work product of an
organization that is certified as a patient safety organization shall
continue to be privileged and confidential, in accordance with this
section, if the organization's certification is terminated or revoked
or if the organization otherwise ceases to qualify as a patient safety
organization.
``(k) Reports on Strategies To Improve Patient Safety.--
``(1) Draft report.--Not later than the date that is 18
months after any National Patient Safety Database is
operational, the Secretary, in consultation with the Director,
shall prepare a draft report on effective strategies for
reducing medical errors and increasing patient safety. The
draft report shall include any measure determined appropriate
by the Secretary to encourage the appropriate use of such
strategies, including use in any federally funded programs. The
Secretary shall make the draft report available for public
comment and submit the draft report to the Institute of
Medicine for review.
``(2) Final report.--Not later than 1 year after the date
described in paragraph (1), the Secretary shall submit a final
report to the Congress that includes, in an appendix, any
findings by the Institute of Medicine concerning research on
the strategies discussed in the draft report and any
modifications made by the Secretary based on such findings.
``SEC. 923. NATIONAL DATABASE.
``(a) Authority.--
``(1) In general.--In conducting activities under this
part, the Secretary shall provide for the establishment and
maintenance of a database to receive relevant nonidentifiable
patient safety work product, and may designate entities to
collect relevant nonidentifiable patient safety work product
that is voluntarily reported by patient safety organizations
upon the request of the Secretary. Any database established or
designated under this paragraph may be referred to as a
`National Patient Safety Database'.
``(2) Use of information.--Information reported to any
National Patient Safety Database shall be used to analyze
national and regional statistics, including trends and patterns
of health care errors. The information resulting from such
analyses may be included in the annual quality reports prepared
under section 913(b)(2).
``(3) Advisory role.--The Secretary shall provide
scientific support to patient safety organizations, including
the dissemination of methodologies and evidence-based
information related to root causes and quality improvement.
``(b) Standards.--In establishing or designating a database under
subsection (a)(1), the Secretary shall, in consultation with
representatives of patient safety organizations, the provider
community, and the health information technology industry, determine
common formats for the voluntary reporting of nonidentifiable patient
safety work product, including necessary elements, common and
consistent definitions, and a standardized computer interface for the
processing of the work product. To the extent practicable, such
standards shall be consistent with the administrative simplification
provisions of part C of title XI of the Social Security Act.
``(c) Certain Methodologies for Collection.--The Secretary shall
ensure that the methodologies for the collection of nonidentifiable
patient safety work product for any National Patient Safety Database
include the methodologies developed or recommended by the Patient
Safety Task Force of the Department of Health and Human Services.
``(d) Facilitation of Information Exchange.--To the extent
practicable, the Secretary may facilitate the direct link of
information between providers and patient safety organizations and
between patient safety organizations and any National Patient Safety
Database.
``(e) Restriction on Transfer.--Only nonidentifiable information
may be transferred to any National Patient Safety Database.
``SEC. 924. TECHNICAL ASSISTANCE.
``(a) In General.--The Secretary, acting through the Director,
may--
``(1) provide technical assistance to patient safety
organizations, and to States with reporting systems for health
care errors; and
``(2) provide guidance on the type of data to be
voluntarily submitted to any National Patient Safety Database.
``(b) Annual Meetings.--Assistance provided under subsection (a)
may include annual meetings for patient safety organizations to discuss
methodology, communication, information collection, or privacy
concerns.
``SEC. 925. CERTIFICATION OF PATIENT SAFETY ORGANIZATIONS.
``(a) In General.--Not later than 6 months after the date of
enactment of the Patient Safety and Quality Improvement Act, the
Secretary shall establish a process for certifying patient safety
organizations.
``(b) Process.--The process established under subsection (a) shall
include the following:
``(1) Certification of patient safety organizations by the
Secretary or by such other national or State governmental
organizations as the Secretary determines appropriate.
``(2) If the Secretary allows other governmental
organizations to certify patient safety organizations under
paragraph (1), the Secretary shall establish a process for
approving such organizations. Any such approved organization
shall conduct certifications and reviews in accordance with
this section.
``(3) A review of each certification under paragraph (1)
(including a review of compliance with each criterion in this
section and any related implementing standards as determined by
the Secretary through rulemaking) not less often than every 3
years, as determined by the Secretary.
``(4) Revocation of any such certification by the Secretary
or other such governmental organization that issued the
certification, upon a showing of cause.
``(c) Criteria.--A patient safety organization must meet the
following criteria as conditions of certification:
``(1) The mission of the patient safety organization is to
conduct activities that are to improve patient safety and the
quality of health care delivery and is not in conflict of
interest with the providers that contract with the patient
safety organization.
``(2) The patient safety organization has appropriately
qualified staff, including licensed or certified medical
professionals.
``(3) The patient safety organization, within any 2 year
period, contracts with more than 1 provider for the purpose of
receiving and reviewing patient safety work product.
``(4) The patient safety organization is not a component of
a health insurer or other entity that offers a group health
plan or health insurance coverage.
``(5) The patient safety organization is managed,
controlled, and operated independently from any provider that
contracts with the patient safety organization for reporting
patient safety work product.
``(6) To the extent practical and appropriate, the patient
safety organization collects patient safety work product from
providers in a standardized manner that permits valid
comparisons of similar cases among similar providers.
``(d) Additional Criteria for Component Organizations.--If a
patient safety organization is a component of another organization, the
patient safety organization must, in addition to meeting the criteria
described in subsection (c), meet the following criteria as conditions
of certification:
``(1) The patient safety organization maintains patient
safety work product separately from the rest of the
organization, and establishes appropriate security measures to
maintain the confidentiality of the patient safety work
product.
``(2) The patient safety organization does not make an
unauthorized disclosure under this Act of patient safety work
product to the rest of the organization in breach of
confidentiality.
``(3) The mission of the patient safety organization does
not create a conflict of interest with the rest of the
organization.''.
(b) Authorization of Appropriations.--Section 937 of the Public
Health Service Act (as redesignated by subsection (a)) is amended by
adding at the end the following:
``(e) Patient Safety and Quality Improvement.--For the purpose of
carrying out part C, there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 2004 through 2013.''.
SEC. 4. PROMOTING THE DIFFUSION AND INTEROPERABILITY OF INFORMATION
TECHNOLOGY SYSTEMS INVOLVED WITH HEALTH CARE DELIVERY.
(a) Voluntary Standards.--
(1) In general.--Not later than 18 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the ``Secretary'')
shall--
(A) develop or adopt voluntary national standards
that promote the interoperability of information
technology systems involved with health care delivery,
including but not limited to computerized physician
order entry;
(B) in developing or adopting such standards, take
into account--
(i) the ability of such systems to capture
and aggregate clinically specific data to
enable evidence-based medicine and other
applications that promote the electronic
exchange of patient medical record information;
and
(ii) the cost that meeting such standards
would have on providing health care in the
United States and the increased efficiencies in
providing such care achieved under the
standards;
(C) in developing or adopting such standards and to
the extent practicable, test the efficacy, usability,
and scalability of proposed interoperability standards
within a variety of clinical settings, including an
urban academic medical center, a rural hospital, a
community health center, and a community hospital; and
(D) submit a report to the Congress containing
recommendations on such standards.
(2) Consultation.--In developing or adopting standards
under paragraph (1)(A), the Secretary shall consider the
recommendations of the National Committee on Vital Health
Statistics for the standardization of message formatting, coding, and
vocabulary for interoperability of information technology systems
involved with health care delivery. The Secretary shall consult with
representatives of the health information technology industry and the
provider community who are involved with the development of
interoperability standards.
(b) Updates.--The Secretary shall provide for the ongoing review
and periodic updating of the standards developed under subsection (a).
SEC. 5. REQUIRED USE OF PRODUCT IDENTIFICATION TECHNOLOGY.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is
amended--
(1) in section 502, by adding at the end the following:
``(w) If it is a drug or biological product, unless it includes a
unique product identifier for the drug or biological product as
required by regulations under section 510(q).''; and
(2) in section 510, by adding at the end the following:
``(q)(1) The Secretary shall issue, and may periodically revise,
regulations requiring the manufacturer of any drug or biological
product that is subject to regulation by the Food and Drug
Administration, or the packager or labeler of a drug or biological
product that is subject to regulation by the Food and Drug
Administration, to include a unique product identifier on the packaging
of the drug or biological product.
``(2) For purposes of this subsection, the term `unique product
identifier' means an identification that--
``(A) is affixed by the manufacturer, labeler, or packager
to each drug or biological product described in paragraph (1)
at each packaging level;
``(B) uniquely identifies the item and meets the standards
required by this section; and
``(C) can be read by a scanning device or other technology
acceptable to the Secretary.
``(3) A unique product identifier required by regulations issued or
revised under paragraph (1) shall be based on--
``(A) the National Drug Code maintained by the Food and
Drug Administration;
``(B) commercially accepted standards established by
organizations that are accredited by the American National
Standards Institute, such as the Health Industry Business
Communication Council or the Uniform Code Council; or
``(C) other identification formats that the Secretary deems
appropriate.
``(4) The Secretary may, at the Secretary's discretion, waive the
requirements of this section, or add additional provisions that are
necessary to safeguard the public health.''.
<all>
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-28.
Placed on the Union Calendar, Calendar No. 19.
Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H1766-1774)
DEBATE - The House proceeded with forty minutes of debate on H.R. 663.
At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
Considered as unfinished business. (consideration: CR H1777-1778)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 418 - 6 (Roll no. 60).(text: CR H1766-1771)
Roll Call #60 (House)On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 418 - 6 (Roll no. 60). (text: CR H1766-1771)
Roll Call #60 (House)Motion to reconsider laid on the table Agreed to without objection.
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Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Measure laid before Senate by unanimous consent. (consideration: CR S8632-8633)
Senate struck all after the Enacting Clause and substituted the language of S. 720 amended.
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Passed Senate with an amendment by Unanimous Consent.
Senate insists on its amendment, asks for a conference, appoints conferees Gregg; Frist; Enzi; Alexander; Kennedy; Dodd; Jeffords.
See also S. 720.
Message on Senate action sent to the House.